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CathWorks FFRangio™ is a software device for the clinical quantitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio™ are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional evaluation.

FFRancio uses standard angiographic images that are retrieved from the X-ray Imaging System (C-arm) in DICOM format. The user selects the images and, following the system prompts, marks key features on the images including the target lesion, ostium location, main vessel, target vessel, and its side branches. The system then matches the corresponding vessels among the projections and generates a 3D computer model of the vessels. The 3D model is used for blood flow analysis and determination of the FFRangio. The modified FFRangio system, designated as model FAU4000, consists of the following components: - Touch screen control console located either as a fixed installation in the cath lab on . an extension arm mounted on the wall or from the ceiling, or on a desktop or mobile cart in the cath lab or control room - Processing Unit located in the cath lab machine room / control room ● - 3D Mouse located at the patient bedside ● - Connection Box located in either the cath lab or control room ● The system supports optional visual media output to the cath lab main displays, so the system GUI may be observed on both the system's Console display and on the cath lab's main display (boom monitor).

CathWorks FFRangio™ is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio™ are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional evaluation.

The FFRangio™ system is a computer system installed on a mobile cart that is to be located inside the catheterization room or in an adjacent technical/viewing area. The cart holds the computer processing unit, user interface control station (LCD screen and keyboard/mouse), medical isolation transformer, and network isolator. Operation requires only connections to mains and a DICOM communication port. The system supports optional visual media output to the Cath Lab main displays, so the system GUI may be observed on both the system's LCD display and on the Cath Lab's main display (boom monitor). FFRancio™ uses standard angiographic images (angiograms) that are retrieved from the X-ray Imaging System (C-arm) in DICOM format. The user selects the images and, following the system prompts, marks key features on the images including the target lesion, ostium location, main vessel, target vessel, and its side branches. The system then matches the corresponding vessels among the projections and generates a 3D computer model of the vessels. The 3D model is used for blood flow analysis and determination of the FFRangio.